Method of surgical repair of vagina damaged by pelvic organ prolapse and prosthetic materials and devices suitable for use therein

ABSTRACT

A method for repairing a vaginal wall ( 35 ) which has been damaged by one or more prolapsed pelvic organs said method including: (a) mobilising the vaginal epithelium off the underlying fascia of at least a portion of the damaged vaginal wall; (b) positioning a prosthetic material ( 36 ) over the exposed fascia; (c) re-fixing the vaginal epithelium over the prosthetic material ( 36 ) and the fascia; and thereafter (d) locating an intra-vaginal splint into the vagina.

This invention relates to a method for the surgical repair of a vaginalwall damaged by the prolapse of any one or more of the pelvic organs,various prosthetic materials and devices useful in such surgery and tokits suitable for use by surgeons when treating women suffering frompelvic organ prolapse.

BACKGROUND TO THE INVENTION

In Australia almost one in four women undergo surgery for pelvic organprolapse. In many other countries the rates are higher. Each year in theUSA approximately 200,000 women undergo pelvic organ prolapse surgery.Pelvic organ prolapse generally involves the descent of the uterus, thebladder or the rectum along the vagina towards (or in extreme casesprotruding beyond) the introitus. Women of advancing years or those thathave borne several children are more frequent sufferers of pelvic organprolapse.

Traditional vaginal surgery is associated with a high failure rate. Itis between 30-40%. Complex and elaborate abdominal, vaginal andlaparoscopic procedures such as abdominal sacral colpopexy, transvaginalsacrospinous ligament fixation and laparoscopic sacral colpopexy havebeen developed to reduce the risk of prolapse recurrence. Unfortunatelythese procedures require a high level of surgical expertise and are onlyavailable to a small number of specialist practitioners and therefore toa small number of patients. Details of various procedures currently inuse are described in Boyles S H., Weber A M, Meyn L.—“Procedures forpelvic organ prolapse in the United States”, 1979-1997. American Journalof Obstetric Gynaecology 2003, 188; 108-115.

More recently there has been a trend towards the use of reinforcingmaterials to support a vaginal wall damaged by prolapse. Prostheticmaterials such as donor fascia lata, pig dermis and various types ofsynthetic mesh have been utilized with mixed success. These materialsare generally positioned under the vaginal wall or walls and suturedinto position. The applicant has recognized that the synthetic meshescurrently in use are far from ideal as they have been designedprincipally for the treatment of anterior abdominal wall herniation andare generally too heavy for the treatment of genital prolapse. Some ofthe meshes in current use are associated with long term problems whichinclude pain with sexual intercourse, erosion of the mesh into the lumenof the vagina (this requires surgery to remedy) and shrinkage of themesh.

It is an object of the present invention to provide a simplifiedsurgical procedure suitable for treatment of different forms of pelvicorgan prolapse. It is a further object to provide an improved prostheticmaterial and device suitable for use in vaginal repair in the treatmentof pelvic organ prolapse.

SUMMARY OF THE INVENTION

In accordance with the first aspect of the present invention there isprovided a method for repairing a vaginal wall which has been damaged byone or more prolapsed pelvic organs, said method including:

-   -   (a) mobilising the vaginal epithelium off the underlying fascia        of at least a portion of the damaged vaginal wall;    -   (b) positioning a prosthetic material over the exposed fascia;    -   (c) re-fixing the vaginal epithelium over the prosthetic        material and the fascia; and thereafter    -   (d) locating an intra-vaginal splint into the vagina.

In this description of the method of the invention and elsewhere in thisspecification (including the claims) the phrase “intra-vaginal splint”means any device sized to be located in the lumen of the vagina andwhich, once located in the lumen of the vagina, will reduce the mobilityof the vaginal walls.

Preferably the prosthetic material once positioned over the exposedfascia is attached to the fascia. Such attachment is usually achieved bysutures, but other methods may be utilised such as by the application ofadhesives or surgical staples.

In some cases of prolapse, repair is required to only one of the vaginalwalls. However, in many cases of prolapse, repair is required to theanterior and posterior walls of the vagina. In such cases it is notimportant whether the anterior or posterior wall is repaired first,although it is usually convenient to repair the anterior wall first.Thus, in accordance with the present invention, if both vaginal wallsare to be repaired, an intra-vaginal splint is located in the vaginaafter prosthetic material has been positioned over the fascias of boththe anterior and posterior vaginal walls and the vaginal epithelium ofboth respective walls has been re-fixed over the prosthetic material andthe fascias.

Therefore, in the case where both the anterior and posterior vaginalwalls are being repaired the preferred method of the invention includesthe following steps:

-   -   (a) mobilising the vaginal epithelium off the underlying fascia        of at least a portion of the anterior vaginal wall;    -   (b) positioning a first prosthetic material over the exposed        fascia of the anterior vaginal wall;    -   (c) re-fixing the vaginal epithelium over the said first        prosthetic material and the fascia of the anterior vaginal wall;    -   (d) mobilising the vaginal epithelium off the underlying fascia        of at least a portion of the posterior vaginal wall;    -   (e) positioning a second prosthetic material over the exposed        fascia of the posterior vaginal wall;    -   (f) re-fixing the vaginal epithelium over the said second        prosthetic material and the fascia of the posterior vaginal        wall; and thereafter    -   (g) locating an intra-vaginal splint into the vagina.

Preferably, the surgery is performed vaginally.

Whether repairing one or both vaginal walls, in most cases theintra-vaginal splint should be removed after the prosthetic material hasbecome incorporated into the vaginal wall tissue. Preferably theintra-vaginal splint remains in position in the vagina for at least 3weeks following insertion. Most preferably the intra-vaginal splint isremoved between 4 to 6 weeks following insertion.

When repairing the anterior vaginal wall, the vaginal epitheliumcovering the fascia is preferably mobilised by incision and lateraldissection—most desirably dissection is carried out to (or proximate to)the arcus tendineous facia pelvie on both sides. If it is only theanterior vaginal wall that is to be repaired it is preferred thatdissection is continued towards the sacrospinous ligaments on bothsides. If both the anterior and posterior walls of the vagina are beingrepaired it is preferred that the dissection of the epithelium of theanterior wall continue through the arcus tendineous fascia pelvie andinto the paravaginal space on each side such that the inner aspect ofthe pubic bone can be palpated. The fascia may be plicated with suturesbefore the first prosthetic material is positioned over the exposedfascia.

Likewise, when repairing the posterior vaginal wall the underlyingfascia (the recto-vaginal septum fascia) may be plicated. The vaginalepithelium covering the posterior wall is preferably mobilised byincision and dissection—laterally to the levator ani muscles on eachside and in the upper part of the vagina, in a lateral and cranialdirection through the rectal pillars on both sides towards thesacrospinous ligaments on each side.

Any of the conventional prosthetic materials currently in use for thetreatment of pelvic organ prolapse can be employed when performing thesurgical methods described above. Thus, a xenograft material, such aspig dermis, an allograft or homograft of skin or a synthetic materialsuitable for reinforcing the vaginal wall might be utilized.

It is preferred however, that the prosthetic material used in the methodof the present invention be a synthetic mesh. More particularly it ispreferred that the prosthetic material have the characteristicsdescribed below in the description of a new synthetic mesh.

The use of an intra-vaginal splint after the positioning of theprosthetic material has been found by the applicant to result inimproved wound healing and a reduced rate of surgical failure. It ispreferred that the intra-vaginal splint used in the methods describedabove have the configuration and characteristics of the newintra-vaginal splint described below.

In accordance with a further aspect of the present invention there isprovided a flexible synthetic mesh for use in the repair of a vaginalwall damaged by the prolapse of one or more pelvic organs said syntheticmesh including a plurality of open pores bounded by strands made ofnon-woven polymeric material, wherein the junctions between therespective strands are without open interstices and wherein a majorityof the open pores of the mesh have an area of less than 15 mm².

Preferably all of the pores of the mesh have an area of less than 15mm². Most preferably, the pore size of a majority of the pores of themesh have an area of less than 10 mm².

The mesh may be of any suitable shape but generally will incorporate acentral body portion and two longitudinal side portions. In the mostpreferred embodiments the pore size in the central body portion of themesh is greater than the pore size in the longitudinal side portions.Most preferably the area of each of the pores in the body of the meshare less than 10 mm² and the area of each of the pores in the sideportions of the mesh will be less than 5 mm². It is also preferred thatthe side portions have a width of at least 3 mm. Most preferably thewidth of the side portions is between 4 and 8 mm.

It is highly desirable that the mesh be light and very flexible.Preferably the mesh has a weight of less than 0.0080 g/cm². Mostpreferably its weight is between 0.0020 and 0.0050 g/cm². Any flexiblebiocompatible polymeric material may be utilised. The preferredpolymeric material is polypropylene and the polypropylene fibres arepreferably monofilament fibres.

The mesh of the present invention does not include any open intersticesat the junctions between the respective strands. This is important tominimise bacterial growth in or around the mesh after it has beenpositioned under the virginal epithelium. Thus the mesh will not bewoven but instead can be formed by stamping the profile out of a sheetof the polymeric material being used or alternatively, adjacent strandsmay be connected in a way which does not produce open interstices at thejunctions between the respective strands. Most conveniently this isachieved by bonding or welding.

The synthetic mesh of the present invention may be produced in asubstantially oval shape for the repair of the anterior vaginal wall andmay be substantially trapezium shaped with two extension arms extendingupwardly and at an angle away from both side portions of the mesh forrepair of the posterior vaginal wall. In a particularly preferredembodiment the oval shaped mesh (intended for use in repairing theanterior vaginal wall) includes two lateral arms, one extending fromeither side portion of the mesh from the mid section on each side.

When using the preferred oval shaped mesh with lateral arms shaped forrepair of the anterior vaginal wall, the mesh is used in the methodsdescribed above by being positioned over the pubocervical fascia witheach lateral arm placed into a tunnel extending from the anteriorvaginal wall dissection to the paravaginal space and the inner aspect ofthe pubic bone.

The preferred mesh described above for use in the method of theinvention for repair of the posterior vaginal wall is positioned overthe recto-vaginal septum fascia with each extension arm placed into thetunnel extending from the posterior vaginal wall dissection to thesacrospinous ligament. The mesh is positioned over the fascia and theposterior vaginal wall epithelium is then closed and re-fixed over themesh to complete the repair.

The prosthetic material, whether it be a preferred synthetic meshdescribed above or some other suitable material is desirably attached tothe respective fascia by using sutures attaching the sides of theprosthetic material to the fascia wall.

Once the vaginal wall or walls have been repaired an intra-vaginalsplint is located in the vagina and preferably sutured into position toprevent extrusion. Alternatively the intra-vaginal splint may includelateral spurs. Preferably the intra-vaginal splint is a semi-rigiddevice and most preferably it is made of a flexible medical gradesilicone. As the vagina does not have a universal shape and size it ispreferred that the surgeon have available to him at least threedifferently sized splints so that a splint may be selected which will beappropriate for the patient being treated. Most desirably, a sizing kitwill be utilized allowing the surgeon to choose the appropriately sizedsplint. The sizing kit should comprise at least three differently sizedmodel splints preferably made of medical grade silicone, so that themodel splints may be sterilized allowing multiple use. The surgeon willchoose the particular sized intra-vaginal splint that matches thecorresponding model intra-vaginal splint from the sizing kit, preferablychoosing the splint that most comfortably fits into the vagina followingthe repair whilst contacting both lateral vaginal walls and the superioraspect of the vagina.

In one form, the intra-vaginal splint includes two longitudinallyextending side arms both having first and second ends; said side armsbeing connected at their respective first ends by a first connectingmember and at their respective second ends by a second connecting memberwherein said first and second connecting members are of differentlengths.

Preferably, the connecting members are straight and are parallel witheach other. Preferably, the longitudinally extending side arms arestraight but are not parallel with each other.

In a most preferred form the intra-vaginal splint is trapezium shaped.The intra-vaginal splint is desirably formed so that the longitudinallyextending side arms are disposed in a first plane in the portion of thesplint proximate the first connecting member and in a second plane(which is at an angle to the first plane) for the remaining portion ofthe splint. Preferably the angle between the respective planes isbetween 8 to 15°. Most desirably it is about 10°.

Preferably the intra-vaginal splint is resilient and bendable about itslongitudinal axis so that on application of a bending force the twolongitudinally extending side members may be brought into closeproximity so that they will be substantially side by side and whereuponrelease of the bending force will result in the longitudinally extendingside arms moving away from each other. This feature facilitates easyinsertion of the splint into the vagina.

All or part of the interior of the splint may be closed by a membrane.In one embodiment the membrane is twin skinned and is inflatable so thatinflation of the membrane once the intra-vaginal splint is in place willpermit the surgeon to tamponade the vagina to prevent and/or controlpost operative bleeding. This may avoid the need to use a vaginal pack.However, if the surgeon wishes to place a vaginal pack this can beplaced around the splint and a urethral catheter can also be placed.Preferably the space between the respective skins or layers of themembrane is in fluid communication with the inside channel of a tubeattached to or integrally formed with one of the membrane skins.

The intra-vaginal splint is used to improve wound healing and strength,reduce movement and displacement of the mesh whilst it is becomingincorporated into the vaginal fascial tissues and to avoid the need touse supporting sutures into structures such as the sacrospinous ligamenthigh onto the uterosacral ligaments or paravaginal tissues. Such suturesare often difficult to place and are associated with significant patientmorbidity.

In a further aspect of the present invention there is provided a kitsuitable for use by surgeons when surgically treating women sufferingfrom pelvic organ prolapse said kit including at least one piece of aflexible synthetic mesh having a plurality of open pores bounded bystrands made of non-woven polymeric material in which junctions betweenthe respective strands are without open interstices and wherein amajority of the open pores of the mesh have an area of less than 15 mm²and one or more differently sized intra-vaginal splints. The flexiblesynthetic mesh may be provided in a sheet so that appropriately shapedsegments can be cut out of the sheet for use in the surgical methods ofthe invention. Preferably the kit includes a selection of pre-shapedmeshes for treatment of both the anterior and posterior vaginal walls inthe preferred shapes, pore sizes and configurations as described above.The kit may also include written directions for the use of thecomponents of the kit in accordance with the surgical methodshereinbefore described.

The present invention is hereafter further described by reference topreferred embodiments with reference to the drawings in which:—

FIG. 1 is a schematic representation of the anterior vaginal wallshowing incision into the vaginal epithelium;

FIG. 2 is a schematic representation of the anterior vaginal wall aftermobilisation of the epithelium;

FIG. 3 is a schematic representation of the anterior vaginal wall withmesh positioned over the exposed fascia and sutured into place;

FIG. 4 is a schematic representation of the anterior vaginal wall afterthe epithelium has been refixed and closed with sutures;

FIG. 5 is a schematic representation of the posterior vaginal wallshowing incision into the epithelium;

FIG. 6 is a schematic representation of the posterior vaginal wall aftermobilisation of the vaginal epithelium;

FIG. 7 is a schematic representation of the posterior vaginal wall withmesh positioned over the exposed fascia and sutured into place;

FIG. 8 is a schematic representation of the posterior vaginal wall afterthe epithelium has been refixed and closed with sutures;

FIG. 9 is a schematic representation of a preferred shape andconfiguration of a mesh of the present invention for repair of theposterior vaginal wall;

FIG. 10 is a schematic representation of a preferred shape andconfiguration of a mesh of the present invention for repair of theanterior vaginal wall;

FIG. 11 is a schematic representation of a preferred intra-vaginalsplint (top view);

FIG. 12 is a schematic representation of the intra-vaginal splint shownin FIG. 11 (side view);

FIG. 13 is a cross-sectioned representation of the intra-vaginal splintshown in FIG. 12 showing the central membrane;

FIG. 14 is a schematic representation of the intra-vaginal splint shownin FIG. 11 (end view);

FIG. 15 is a perspective schematic representation of the intra-vaginalsplint shown in FIG. 11;

FIG. 16 is a schematic representation of an intra-vaginal splint of theinvention incorporating an inflatable membrane;

FIG. 17 is a side view of the intra-vaginal splint shown in FIG. 16 withthe membrane inflated;

FIG. 18 is a schematic representation of a kit of three differentlysized model intra-vaginal splints;

FIG. 19 is a schematic representation showing the positioning of a meshreinforcing the posterior vaginal wall; and

FIG. 20 depicts the intra-vaginal splint once placed within the vagina.

Turning to FIG. 1 there is shown the open vagina (1) and anteriorvaginal wall (2). The vaginal wall (2) is covered by an epithelium layer(3). An incision into the vaginal epithelium is shown in FIG. 1. Oncethe initial incision along the vaginal epithelium layer (3) has beencarried out the epithelium (3) is peeled and held away from the fascia(6) as shown in FIG. 2. This lateral dissection is carried out to andthen through the arcus tendinous fascia pelvie on both sides, and intothe paravaginal spaces on each side. The fascia (6) is preferablyplicated (not shown) once the epithelium (3) has been mobilized off thefascia wall. Mesh (7) is then positioned over the defect (4) of theexposed fascia (6). This is with each lateral extension arm (7 a, 7 b)of the mesh (7) placed into the ipsilateral paravaginal space such thatthe lateral extension arms (7 a, 7 b) come into contact with the inneraspect of the pubic bone. The mesh (7) shown in FIG. 3 can be seen ingreater detail in FIG. 10. The mesh (7) has a central body portion (8)which is substantially oval in shape and which has top to baselongitudinal side portions (9 and 10) which merge into the lateralextension arms (7 a, 7 b). For most cases a mesh having a dimension ofabout 50 mm and a width (excluding the lateral extension arms) ofbetween about 30-40 mm will suffice. The lateral extension arms (7 a, 7b) in most cases will be about 30 mm long and 20 mm in width. It will beappreciated that the mesh size will depend largely on the dimensions ofthe vaginal wall being repaired. The mesh shown in FIGS. 3 and 10 ismade from polypropylene. In the central body portion (8) of the mesh (7)the area of each of the pores is approximately 9 mm² (3 mm×3 mm). Theside portions (9 and 10) and extension arms (7 a, 7 b) have a pore sizeof approximately 3 mm² (1 mm×3 mm). The mesh is made from monofilamentpolypropylene and is a bonded or welded mesh having a weight of about0.003 g/cm². Once the mesh (7) has been positioned over the fascia (6)of the anterior vaginal wall (2) it is attached onto the fascia (6) bysutures (11). Excess vaginal epithelium is then trimmed and the anteriorvaginal wall is closed by sutures (12) as shown in FIG. 4.

Repair of the posterior vaginal wall is shown in FIGS. 5 to 8. In FIG. 5posterior vaginal wall (13) is shown with the epithelium (14) of theposterior vaginal wall in place. A longitudinal incision is performed inorder to mobilise the epithelium (14) off the underlying fascia (15) asshown in FIG. 5. The defect 15 a in fascia 15 is illustrated in FIG. 6.Dissection is carried out laterally to the levator ani muscles on eachside. This is also depicted in FIG. 6. In the upper part of the vagina,dissection is continued in a lateral and cranial direction through therectal pillars on both sides towards the sacrospinous ligaments on eachside. This forms bilateral tunnels from the posterior vaginal walldissection to each sacrospinous ligament. The fascia of therecto-vaginal septum is preferably plicated (not shown). The pre-shapedmesh (16) designed for the posterior vaginal wall repair is shown inFIGS. 7 and 9. It is placed over the recto-vaginal septum facia (15)with each extension arm (17,18) placed into the tunnel extending fromthe posterior vaginal wall dissection to the sacrospinous ligament. Thepositioning of the mesh (16) is more clearly depicted in FIG. 19 whichshows its location relative to the sacrospinous ligament (33), therectum (34) and the vagina (35). Turning to FIG. 9 it can be seen thatthe pre-shaped mesh (16) designed for the posterior vaginal wall (13)repair has a central body portion (19) and longitudinal side portions(20) and (21). The width of this mesh varies from about 3 cm at the baseto 11 cm at the top. The width at the top (22) of the central bodyportion (19) of the mesh (16) is about 6 cm. The midline length of themesh (16) is about 7 cm and the length of each extension arm (17,18) isabout 5 cm with a width of about 1.5 cm. Again the mesh (16) is madefrom monofilament polypropylene and is a bonded or welded mesh having aweight of about 0.0030 g/cm². The area of the pore size of each of thepores of the central body portion (19) of the mesh is approximately 9mm² (3×3 mm) and at the longitudinal side portions (20,21) approximately3 mm² (1×3 mm).

Once the mesh (16) has been positioned over the fascia, it is anchoredinto place by sutures (23) as shown in FIG. 7. Excess posterior vaginalwall epithelium (14) is trimmed and the vaginal epithelium (14) isrefixed over mesh (16) as shown in FIG. 8.

At this point the intra-vaginal splint sizing kit shown in FIG. 18 isused. The surgeon selects from the kit the appropriately sized splint.Once the correct size for the intra-vaginal splint has been determinedby using the model splints from the kit, the intra-vaginal splint isinserted into the vagina and sutured into position to prevent extrusion.This is best seen in FIG. 20 where vaginal splint (36) is shownpositioned within the vagina (35). The intra-vaginal splint shown inFIG. 11 has small apertures (33) at one end for receiving sutures.

The preferred intra-vaginal splint is shown in FIGS. 11 to 17. Itincludes longitudinally extending side arms (24) and (25), andconnecting members (26) and (27). Preferably the base (30) of the splint(that section extending about 20 mm from the connecting member (26) isinclined at about 10° from the remaining portion (31) of the splint.This is best seen in FIGS. 12 and 13. The central part of the splint isclosed by a silicone membrane (32). In one embodiment the membrane istwin skinned and is inflatable—see FIG. 16. Inflation of the membranewith fluid is possible through tube 32 a which provides a fluid channelinto the space between the respective layers 32 b ad 32 c of themembrane. This is shown in FIG. 16 (perspective view) and 17 (sideview).

The intra-vaginal splint is preferably retained in the vagina for aperiod of four weeks. Once this period has elapsed the splint can beremoved by which time the synthetic mesh should have become incorporatedinto the tissue of each of the respective vaginal walls.

Clinical Trial Results

The method of the invention has been the subject of a clinical trialinvolving 49 women. The mean age of the women was 57.7 years (range34-79) and mean parity of 2.8 (range 1-6). Twenty-two women (45%) hadundergone a prior hysterectomy and 21 (43%) at least one surgicalprocedure for pelvic organ prolapse. Nine women (18%) had undergonesurgery for stress incontinence and five (10.2%) women had undergone twoor more operations for pelvic organ prolapse.

The operations performed on the 49 women are detailed in Table 1 set outbelow. A synthetic mesh was used for the anterior vaginal repair only in5 women, posterior vaginal repair only in 32 women and both anterior andposterior repairs in 12 women.

When mesh was used in the anterior vaginal repair only, the vaginalepithelium was dissected off the underlying fascia. Laterally,dissection continued until each arcus tendineus fascia pelvis wasreached. Superior and lateral, dissection continued until eachsacrospinous ligament was reached. A Y-shaped piece of synthetic meshwas placed over the fascia with the extension arms of the mesh beingplaced in the tunnels created by the dissection onto the sacrospinousligaments. Sutures were not placed in the sacrospinous ligaments. Themesh was placed loosely and fixed in place with two to three suturessecuring the mesh onto the fascia. Excess vaginal epithelium was removedand the epithelium closed over the mesh.

When mesh was used to reinforce the posterior vaginal repair, thevaginal epithelium was dissected off the underlying fascia. Dissectioncontinued laterally on each side to the levator ani muscles. Superiorand lateral, the dissection continued through the rectal pillars to eachsacrospinous ligament. A “Y-shaped” piece of mesh was placed over thefascia with the extension arms of the mesh being placed in the tunnelscreated by the dissection onto the sacrospinous ligaments so that themesh abutted each sacrospinous ligament. Sutures were not placed intothe sacrospinous ligaments. Excess epithelium was removed and theposterior vaginal wall epithelium closed over the mesh.

When mesh was used for to reinforce both anterior and posterior vaginalwalls, the mesh was placed under the posterior vaginal wall epitheliumas described above. The placement of mesh under the anterior vaginalwall epithelium differed from the technique described above. Lateraldissection was continued through each arcus tendineus fascia pelvi intoright and left paravaginal spaces so the inner aspect of the pubic bonecould be palpated. Anteriorly, there was no dissection onto thesacrospinous ligaments. A “cross-shaped” piece of mesh was cut andplaced over the fascia with the extension arms being placed into eachparavaginal space so that the mesh abutted the inner aspect of the pubicbone on each side.

All patients received prophylactic antibiotic therapy that was continuedfor 48 hours following surgery. Clexane was routinely used in eachpatient and continued until the patient was discharged from hospital.

At the completion of surgery an appropriately sized intra-vaginal splintwas placed in the vagina and sutured in place to prevent dislodgement.The vaginal splint was made of medical grade silicone and three sizeswere used for the purposes of sizing. After the patient was discharged,the first review was at four weeks to remove the intra-vaginal splint inthe consulting room. By four weeks the sutures holding the vaginalsplint in place had dissolved.

Results

Patients were reviewed four weeks following surgery to remove thevaginal splint. No woman had developed further symptomatic or objectiveevidence of grade 2 (Baden-Walker classification) or more pelvic organprolapse. No major intraoperative or postoperative complicationsoccurred.

Discussion

Following surgery for pelvic organ prolapse the repair is exposed torises in intra-abdominal pressure as the patient mobilizes or withcoughing, vomiting and straining with bowel evacuation. Potentially,rises in intra-abdominal pressure may adversely effect the healing ofthe vaginal repair leading to surgical failure and recurrent prolapse.By reinforcing the vaginal repair with mesh and supporting the vaginawith a splinting device for four weeks following surgery the risk ofsurgical failure and recurrent pelvic organ prolapse has been reduced.Mesh is incorporated into the body tissues at three weeks. The vaginalsplinting device not only supports the vaginal tissues after surgery butalso supports the position of the mesh. By supporting the position ofthe mesh until incorporation into the body tissues occurs it is possibleto avoid placing sutures into the sacrospinous ligaments or paravaginalspaces. This makes surgery much simpler to perform and avoids thespecific complications, which can occur with suture placement into thesestructures.

This procedure is sufficiently simple for general gynaecologists,urogynaecologists and urologists to perform. TABLE 1 Details of surgeryperformed for pelvic organ prolapse Surgery Cases (n) Surgery using meshAnterior repair 5 Posterior repair 32 Anterior & posterior repair withmesh 12 Additional Surgical Procedures Anterior repair without mesh 7Posterior repair without mesh 1 TVT 10 Laparoscopic colposuspension 13Laparoscopic paravaginal repair 14 Vaginal hysterectomy 11 Laparoscopicsacral hysteropexy 3 Urethral reconstruction 1 Transvaginal urethrolysis2 Martius graft 1 Laparoscopic tubal ligation 1 Laparoscopicoophorectomy 1 Laparoscopic adhesiolysis 1 Vaginoplasty for vaginalstenosis 1 Anal sphincter repair 3

The present invention involves a simplified procedure for the treatmentof pelvic organ prolapse and vaginal repair. The meshes described aresignificantly better suited for vaginal surgery as compared with meshesavailable in the past and in current use and the surgical method enablessurgeons to treat prolapse without using complex abdominal, vaginal orlaparoscopic procedures.

1. A method for repairing a vaginal wall which has been damaged by oneor more prolapsed pelvic organs said method including: (a) mobilisingthe vaginal epithelium off the underlying fascia of at least a portionof the damaged vaginal wall; (b) positioning a prosthetic material overthe exposed fascia; (c) re-fixing the vaginal epithelium over theprosthetic material and the fascia; and thereafter (d) locating anintra-vaginal splint into the vagina.
 2. A method as claimed in claim 1wherein the vaginal wall being repaired is the anterior vaginal wall andthe vaginal epithelium is mobilised off the underlying fascia byincision and lateral dissection through the arcus tendineous fasciapelvie and continued towards the sacrospinous ligaments on both sides.3. A method as claimed in claim 1 wherein the vaginal wall beingrepaired is the anterior vaginal wall and the vaginal epithelium ismobilised off the underlying fascia by incision and lateral dissectionthrough the arcus tendineous fascia pelvie and into the paravaginalspace on each side of the anterior vaginal wall.
 4. A method as claimedin claim 3 wherein the said prosthetic material is a synthetic meshhaving laterally extending arms on both sides and the said mesh ispositioned over the exposed fascia of the anterior vaginal wall witheach lateral arm of the mesh placed into tunnels extending from theanterior vaginal wall dissection into the paravaginal spaces.
 5. Amethod as claimed in claim 1 wherein the vaginal wall being repaired isthe posterior wall of the vagina and the vaginal epithelium is mobilisedoff the underlying fascia by incision and dissection laterally to thelevator ani muscles on each side and in the upper part of the vagina ina lateral and cranial direction through the rectal pillars on both sidestowards the sacrospinous ligaments on each side of the vaginal wall. 6.A method as claimed in claim 5 wherein the prosthetic material is asynthetic mesh having upwardly extending arms and the synthetic mesh ispositioned over the exposed fascia of the posterior vaginal wall witheach upwardly extending arm of the synthetic mesh being placed into thetunnel extending from the posterior vaginal wall dissection to therespective sacrospinous ligament.
 7. A method as claimed in any one ofthe previous claims wherein said prosthetic material once positionedover the exposed fascia of the vaginal wall being repaired is thereafterattached to the underlying fascia by sutures.
 8. A method as claimed inany one of the previous claims wherein the fascia of the damaged vaginalwall is plicated after the vaginal epithelium has been mobilized butprior to the positioning of a prosthetic material over the exposedfascia.
 9. A method as claimed in any one of the preceding claimswherein the intra-vaginal splint once located within the vagina isattached to the adjacent vaginal epithelium by sutures.
 10. A method asclaimed in any one of claims 1 to 9 wherein said intra-vaginal splintremains located within the vagina for a period of at least three weeksfollowing location within the vagina.
 11. A method as claimed in claim10 wherein said intra-vaginal splint remains located within the vaginafor a period of between 4 to 6 weeks following location within thevagina.
 12. A method for repairing the anterior and posterior vaginalwalls of the vagina damaged by one or more prolapsed pelvic organs, saidmethod including: (a) mobilizing the vaginal epithelium off theunderlying fascia of at least a portion of the anterior vaginal wall;(b) positioning a first prosthetic material over the exposed fascia ofthe anterior vaginal wall; (c) re-fixing the vaginal epithelium over thesaid first prosthetic material and the fascia of the anterior vaginalwall; (d) mobilizing the vaginal epithelium off the underlying fascia ofat least a portion of the posterior vaginal wall; (e) position a secondprosthetic material over the exposed fascia of the posterior vaginalwall; (f) re-fixing the vaginal epithelium over the second prostheticmaterial and the fascia of the posterior vaginal wall; and thereafter(g) locating an intra-vaginal splint into the vagina.
 13. A method asclaimed in claim 12 wherein said intra-vaginal splint is attached to theadjacent vaginal epithelium by sutures.
 14. A method as claimed ineither one of claims 12 or 13 wherein said intra-vaginal splint remainslocated within the vagina for a period of at least three weeks followinglocation within the vagina.
 15. A method as claimed in claim 14 whereinsaid intra-vaginal splint remains located within the vagina for a periodof between 4 to 6 weeks following location within the vagina.
 16. Aflexible synthetic mesh for use in the repair of a vaginal wall damagedby the prolapse of one or more pelvic organs said synthetic meshincluding a plurality of open pores bounded by strands made of non-wovenpolymeric material, wherein the junctions between the respective strandsare without open interstices and wherein a majority of the open pores ofthe mesh have an area of less than 15 mm².
 17. A flexible synthetic meshas claimed in claim 16 wherein all of the open pores of the mesh have anarea of less than 15 mm².
 18. A flexible synthetic mesh as claimed inclaim 16 wherein the majority of the open pores of the mesh have an areaof less than 10 mm².
 19. A flexible synthetic mesh as claimed in any oneof claims 16 to 18 which incorporates a central body portion and twolongitudinal side portions and in which the size of the open pores ofthe mesh in the central body portion is greater than the size of theopen pores of the mesh in the longitudinal side portions.
 20. A flexiblesynthetic mesh as claimed in claim 19 wherein the area of each of theopen pores in the central body portion is less than 10 mm² and the areaof each of the open pores in the side portions of the mesh is less than5 mm².
 21. A flexible synthetic mesh as claimed in any one of claims 16to 20 wherein the mesh has a weight of less than 0.0080 g/cm².
 22. Aflexible synthetic mesh as claimed in claim 21 wherein the weight of themesh is between 0.0020 and 0.0050 g/cm².
 23. A flexible synthetic meshas claimed in any one of claims 16 to 22 wherein said mesh issubstantially oval in shape with a first lateral arm extending from oneside of the said mesh and a second lateral arm extending from the otherside of said mesh.
 24. A flexible synthetic mesh as claimed in any oneof claims 16 to 22 wherein said mesh is substantially trapezium shapedwith a first extension arm extending upwardly and at an angle away fromone side portion of the mesh and a second extension arm extendingupwardly and at an angle way from the other side portion of the mesh.25. An intra-vaginal splint which includes two longitudinally extendingside arms both having first and second ends, said side arms beingconnected at their respective first ends by a first connecting memberand at their respective second ends by a second connecting memberwherein said first and second connecting members are of differentlengths.
 26. An intra-vaginal splint as claimed in claim 25 is made froma flexible medical grade silicone.
 27. An intra-vaginal splint asclaimed in either claim 25 or claim 26 wherein said splint issubstantially trapezium shaped.
 28. An intra-vaginal splint as claimedin any one of claims 25 to 27 wherein all or part of the interior of thesplint is closed by a membrane.
 29. An intra-vaginal splint as claimedin claim 28 wherein the membrane is twin walled and is inflatable. 30.An intra-vaginal splint as claimed in any one of claims 25 to 29 whereinthe longitudinally extending side arms are disposed in a first plane inthe portion of the splint proximate the first connecting member and in asecond plane, which is at an angle to the first plane, for the remainingportion of the intra-vaginal splint.
 31. An intra-vaginal splint asclaimed in claim 30 wherein the angle between the respective planes isbetween 8 to 15°.
 32. An intra-vaginal splint as claimed in claim 31wherein the angle between the respective planes is about 10°.
 33. Amethod as claimed in any one of claims 1 to 15 wherein the prostheticmaterial is a flexible synthetic mesh as claimed in any one of claims 16to
 24. 34. A method as claimed in any one of claims 1 to 15 wherein theintra-vaginal splint is a splint as claimed in any one of claims 25 to32.
 35. A kit suitable for use in repairing a vaginal wall of the vaginaof a woman suffering from pelvic organ prolapse; said kit including atleast one piece of a flexible synthetic mesh having a plurality of openpores bounded by strands made of non-woven polymeric material in whichjunctions between the respective strands are without open intersticesand wherein a majority of the open pores of the mesh have an area ofless than 15 mm² and a range of three or more differently sizedintra-vaginal splints.
 36. A kit as claimed in claim 35 containing threeor more intra-vaginal splints of the type claimed in any one of claims25 to
 32. 37. A kit as claimed in either one of claims 35 or 36 whichcontains at least one pre-shaped piece of flexible synthetic mesh asclaimed in claim 23 and at least one pre-shaped piece of flexiblesynthetic mesh as claimed in claim
 24. 38. A kit as claimed in any oneof claims 35 to 37 also including written directions to use the flexiblesynthetic mesh and the intra-vaginal splints of the said kit inaccordance with a method as claimed in any one of claims 1 to 15, 33 or34.
 39. A method substantially as hereinbefore described with particularreference to what is shown in any one or more of the drawings.
 40. Aflexible synthetic mesh substantially as hereinbefore described withreference to what is shown in FIG.
 9. 41. A flexible synthetic meshsubstantially as hereinbefore described with reference to what is shownin FIG.
 10. 42. An intra-vaginal splint substantially as hereinbeforedescribed with reference to what is shown in any one of FIGS. 11 to 17.